Allopurinol and Endothelial Function in Diabetic CAD Patients

Not Applicable

• Conditions: Coronary Artery Disease; Diabetes Mellitus
• Interventions: Drug: Allopurinol

• Registration Number: NCT03385135
• Lead Sponsor: University Tunis El Manar

Brief Summary

This is a randomized trial assessing the impact of allopurinol on endothelial function in optimally treated diabetic patients with coronary artery disease. After initial screening, subjects were randomized to receive either optimal medical therapy (OMT) + allopurinol or OMT alone for 8 weeks. The dose of allopurinol was 300 mg for 4 weeks and 600 mg for 4 weeks with a 4-weekly check on hematology and biochemistry

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-12
• Study Start: 2017-12
• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-26
• Last Update Submitted: 2017-12-26
• Study First Posted: 2017-12-28
• Last Update Posted: 2017-12-28
• Primary Completion: 2018-03
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Diabetes type 2
• Known coronary artery disease with previous percutaneous coronary intervention and optimal medical therapy for at least one month

Exclusion Criteria

• Pregnant or breast- feeding women
• creatinine clearance <60ml/min
• Known history of gout disease or ongoing treatment with allopurinol
• Allergy to allopurinol
• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allopurinol group	Allopurinol	Optimal medical therapy associated with allopurinol. The dose of allopurinol is 300 mg for 4 weeks then 600 mg for 4 weeks

Primary Outcome Measures

Name	Time	Method
Endothelium-dependent vasodilation	2 months	Brachial Artery Flow-Mediated dilation (FMD)

Secondary Outcome Measures

Name	Time	Method
Endothelium-independent vasodilation	2 months	Changes in brachial artery diameter in response to nitrates
Quality of Life (QoL)	2 months	Seattle Angina Questionnaire: a scale that quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Major adverse cardiac events (MACE)	2 months	composite of cardiac death, non fatal myocardial infarction and unplanned coronary revascularization

Trial Locations

Locations (1)

Cardiology Department, Abderrahmen Mami Hospital; 🇹🇳 Ariana, Tunisia